The impact of post-market regulatory safety advisories on patients, prescribers, and the healthcare system

Author:

Puil Lorri1,Lexchin Joel2,Bero Lisa3,Mangin Dee4,Hallgreen Christine E5,Wong Gavin WK6,Mintzes Barbara3

Affiliation:

1. University of British Columbia; Department of Anesthesiology, Pharmacology and Therapeutics, Faculty of Medicine; 2176 Health Sciences Mall Vancouver BC Canada V6T 1Z3

2. York University; School of Health Policy and Management; 121 Walmer Rd Toronto ON Canada M5R 2X8

3. The University of Sydney; Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health; D17, 6th floor, Charles Perkins Centre, , The University of Sydney | NSW | 2006 Camperdown, Sydney NSW Australia 2006

4. McMaster University; Family Medicine; Hamilton Canada

5. University of Copenhagen; Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy, Faculty of Health and Medical Sciences; Universitetsparken 2 Copenhagen Denmark 2100

6. University of British Columbia; Centre for Clinical Epidemiology and Evaluation; 828 West 10th Avenue Vancouver British Columbia Canada V5Z 1M9

Publisher

Wiley

Subject

Pharmacology (medical)

Reference92 articles.

1. Australian Government Department of Health Therapeutics Good Administration ACSS NAS work-sharing pilot, 2018 www.tga.gov.au/acss-nas-work-sharing-initiative#pilot

2. Agarwal A Guyatt G Busse J Methods commentary: risk of bias in cross-sectional surveys of attitudes and practices, 2011 www.evidencepartners.com/resources/methodological-resources/risk-of-bias-cross-sectional-surveys-of-attitudes-and-practices/

3. Adverse-drug-reaction-related hospitalizations in developed and developing countries: a review of prevalence and contributing factors;Angamo;Drug Safety,2016

4. Post-marketing drug withdrawals: pharmacovigilance success, regulatory problems;Aronson;Therapie,2017

5. GRADE guidelines: 3. Rating the quality of evidence;Balshem;Journal of Clinical Epidemiology,2011

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